Incident Report
Subform I: General Information
1. Report Type.
New incident report
Incident Report Number: 2023-4536
2. Registrant Information.
Registrant Reference Number: AEINBX_05
Registrant Name (Full Legal Name no abbreviations): Bayer CropScience Inc.
Address: 160 Quarry Park Boulevard SE Suite 130
City: CALGARY
Prov / State: AB
Country: CANADA
Postal Code: T2C 3G3
3. Select the appropriate subform(s) for the incident.
Human
4. Date registrant was first informed of the incident.
09-AUG-23
5. Location of incident.
Country: UNITED STATES
Prov / State: MASSACHUSETTS
6. Date incident was first observed.
Unknown
Product Description
7. a) Provide the active ingredient and, if available, the registration number and product name (include all tank mixes). If the product is not registered provide a submission number.
Active(s)
PMRA Registration No.
PMRA Submission No.
EPA Registration No. Unknown
Product Name: Roundup (Unspecified)
7. b) Type of formulation.
Liquid
Application Information
8. Product was applied?
Yes
9. Application Rate.
Unknown
10. Site pesticide was applied to (select all that apply).
Site: Unknown / Inconnu
11. Provide any additional information regarding application (how it was applied, amount applied, the size of the area treated etc).
Please see detailed case information.
To be determined by Registrant
12. In your opinion, was the product used according to the label instructions?
Unknown
Subform II: Human Incident Report (A separate form for each person affected)
1. Source of Report.
Data Subject
2. Demographic information of data subject
Sex: Female
Age: >64 yrs / > 64 ans
3. List all symptoms, using the selections below.
System
- General
- Symptom - Lethargy
- Symptom - Cancer
- Nervous and Muscular Systems
4. How long did the symptoms last?
Anticip. permanent/Permanence anticipée
5. Was medical treatment provided? Provide details in question 13.
No
6. a) Was the person hospitalized?
No
6. b) For how long?
7. Exposure scenario
Unknown
8. How did exposure occur? (Select all that apply)
9. If the exposure occured during application or re-entry, what protective clothing was worn? (select all that apply)
Unknown
10. Route(s) of exposure.
Unknown
11. What was the length of exposure?
Unknown / Inconnu
12. Time between exposure and onset of symptoms.
Unknown / Inconnu
13. Provide any additional details about the incident (eg. description of the frequency and severity of the symptoms, type of medical treatment, results from medical tests, outcome of the incident, amount of pesticide exposed to, etc.)
Caller contacted Bayer Corporation (United States) and stated the following:They are reaching out regarding the Round-up settlements. They were diagnosed with non-Hodgkin's Lymphoma (MZL) on 11/25/2020. Doctor at the time was concerned about their high WBC in pre-op blood work before hip replacement at the age of 65 years old. Doctor referred to a hemi-oncologist which led to diagnosis of MZL, and stated it was probably there for a while. They continue to be under the oncologists care and his doctor. They haven't as of yet needed treatment but oncologist warned it is a question of when. They report being under unbearable stress at times and struggles with tiredness everyday. He states already receiving a gross award and is seeking further compensation due to concerns for the higher potential costs of medication.
To be determined by Registrant
14. Severity classification.
Major
15. Provide supplemental information here.
Glyphosate has a wide margin of safety in humans and is not known to be a cause of cancers in humans. Glyphosate has been recognized by the PMRA as not presenting a carcinogenic risk to humans.